HEPARIN ASSAY CONTROLS
FDA 510(k) clearance K103313 · decided 2010-12-01
Clearance details
- K-number
- K103313
- Device name
- HEPARIN ASSAY CONTROLS
- Applicant
- Medtronic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-11-10
- Decision date
- 2010-12-01
- Days to decision
- 21 days
- Clearance type
- Special
- Product code
- GGN
- Device class
- 2
- Regulation number
- 864.5425
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mounds View, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.
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